Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT01785433
Brief Summary:
The primary objective of this study is to assess and compare the pharmacokinetics (PK) of Tiotropium delivered via Breath Actuated Inhaler (BAI) (4.5 mcg/day or 9.0 mcg/day), SPIRIVA®, HandiHaler®, (18 mcg/day) and Respimat® Soft Mist™ Inhaler (SMI) (5.0 mcg/day) following repeat dosing for 7 days in subjects with COPD.
Detailed Description:
This multicenter study consists of a Screening Visit (3 to 14 days prior to randomization); 4 multiple-dose (7-day) Treatment Periods, each consisting of a 2-night/3-day inpatient stay (Day 6 to Day 8); and a Final Visit. A washout period of at least 21 days will occur between each Treatment Period. The Final/ Early Termination Visit will occur 6-8 days following the last Treatment Period or upon early discharge from the study.
Study:
NCT01785433
Study Brief:
Protocol Section:
NCT01785433